Sedation of children prior to the surgery using nebulization of two doses of a same drug called dexmedetomidine to reduce parental separation anxiety.

Phase 3

Not yet recruiting

• Registration Number: CTRI/2022/02/040637
• Lead Sponsor: Gauhati Medical College

Brief Summary

Preoperative anxiety is seen in 50%-70% of the pediatric patients posted for surgery1.Fear of parent separation,fear of strange hospital environment and painful procedures contribute to preoperative anxiety2.Children with high preoperative anxiety have high incidence of postoperative pain,emergence delirium, delayed discharge and maladaptive and behavioural  changes that can last for weeks in postoperative period3.Various drugs have been advocated as premedication to allay anxiety,reduce fear of parental separation and facilitate smooth induction of anesthesia.To date,there is no widely accepted standard regimen or an ideal route of administration for  premedication .The ideal premedicant in children should be readily acceptable and should have a rapid and reliable onset with minimal side effects.Inhalation of nebulised drug is an easy alternative for preoperative sedation as it avoids needle puncture.However, systemic absorption of the nebulised drug depends on multiple factors,such as dosage of the drug,properties  of the drug and nebulizer used.Other drugs such as midazolam , ketamine have been tried via oral,nasal and parenteral routes, but each one has its own limitations4.                                                              Dexmedetomidine ,a selective alpha-2 agonist with central sedative and anxiolytic,has been tried as  preoperative anxiolytic  via nasal and inhalational routes in pediatric patients.Dexmedetomidine nebulisation is an attractive option as pediatric premedication.However,the effective dose is not well established in pediatric patients.So in our study,we want to compare the doses of 2 mcg/kg and 3mcg/kg and study their effects.The null hypothesis of our study is that there is no difference in parental separation and mask acceptance in patients when 2mcg/kg or 3 mcg/kg dexmedetomidine is used as premedication.

References :

1.Anupriya J, Kurhekar P. Randomised Comparison between the Efficacy of Two Doses of Nebulised Dexmedetomidine for Premedication in Paediatric Patients. Turk J Anaesthesiol Reanim. 2020 Aug;48(4):314-320. doi: 10.5152/TJAR.2019.78889. Epub 2019 Oct 17. PMID: 32864647; PMCID: PMC7434347.   2.Tan L, Meakin GH. Anaesthesia for uncooperative child. Continuing Education in Anaesthesia Crit Care Pain. 2010;10:48–52. doi: 10.1093/bjaceaccp/mkq003.   3.Fortier MA, Kain ZN. Treating perioperative anxiety and pain in children: A tailored and innovative approach. Paediatr Anaesth. 2015;25:27–35. doi: 10.1111/pan.12546.   4.Sullivan MO, Wong GK. Preinduction techniques to relieve anxiety in children undergoing general anaesthesia. Continuing Education in Anaesthesia Crit Care Pain. 2013;13:196–9. doi: 10.1093/bjaceaccp/mkt014.   5.Zanaty OM, El Metainy SA. A comparative evaluation of nebulized dexmedetomidine, nebulized ketamine, and their combination as premedication for outpatient pediatric dental surgery. Anesth Analg. 2015 Jul;121(1):167-71. doi: 10.1213/ANE.0000000000000728. PMID: 25822924   6. Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz HM, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012;67(11):1210–6.

7.WeldonBC,Watcha MF,White PF.Oral midazolamin children:effect of time ad adjunctive therapy.Anesth Analg 1992;75:51-5

8..Akin A,Bayram A, Esmaoglu A,Tosun Z,Aksu R,Altuntas R,et al.Dexmedetomidine vs midazolam for premedication of pediatric patients undergoing anesthsia.Paediatr Anaesth 2012;22:871-6

9.Macnab AJ, Levine M, Glick N,Susak L,Baker-Brown G.A reasearch tool for measurement of recovery from sedation: the Vancouver Sedative Recovery Scale. J Pediatr Surg1991;26:1263-7

10.Büttner W, Finke w. Analysis of behavioural and physiological parameters for the assessment of postoperative analgesic demand in newborns,infants and young children: a comprehensive report on seven consecutive studies.Paediatric Anaesth 2000;10:303-18

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-23
• Study Start: 2022-03-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• 1.Age group 1-8 years.
• 2.American Society of Anaesthesiologists physical status 1 or 2 3.Availability of informed consent.
• 4.Any gender.

Exclusion Criteria

• Parents refusal.
• 2.Patients with history of cardiac disease,asthma,seizure disorders.
• 3.patients with mental retardation,developmental delay or any congenital anomalies.
• 4.Patients with known allergy to dexmedetomidine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parental seperation anxiety score and mask acceptance score	30 mins after beginning of nebulisation.

Secondary Outcome Measures

Name	Time	Method
To access emergence agitation post operatively.	Immediately after emergence
To access hemodynamic variables intraoperatively.
To access post operative sedation.	1 hour and 2 hours post operatively.

Trial Locations

Locations (1)

Gauhati Medical College; 🇮🇳 Kamrup, ASSAM, India

Gauhati Medical College

🇮🇳Kamrup, ASSAM, India

Dr Sushmita Mazumder

Principal investigator

9613960791

sushmitamazumder68@gmail.com